• 25 Nov 2025
• Admin
• News Article

NeuroSense Secures FDA Authorization to Launch Phase 3 Trial of PrimeC for ALS

The race to develop effective treatments for amyotrophic lateral sclerosis (ALS) took a significant step forward this week. NeuroSense Therapeutics has received FDA clearance to initiate its pivotal Phase 3 clinical trial evaluating PrimeC, the company’s lead drug candidate.

The approval follows the FDA’s completed review of NeuroSense’s IND amendment, giving the company a green light to begin enrolling patients in the coming months once final resources are secured.

Why This Matters for ALS Treatment?

ALS remains one of the most devastating neurodegenerative diseases, with patients typically surviving only 2–5 years after diagnosis. Treatment options are limited, and the unmet medical need is enormous.

PrimeC aims to change this trajectory using a multi-target, synergistic approach designed to slow motor neuron degeneration at its biological roots.

NeuroSense CEO Alon Ben-Noon describes the milestone as:

“A meaningful advancement for NeuroSense and for people living with ALS.”

Inside PARAGON: The Pivotal Phase 3 Trial

The Phase 3 trial—named PARAGON—will build on the promising results from the Phase 2b PARADIGM study, which showed encouraging clinical and biomarker outcomes along with strong safety and tolerability.

Key Trial Highlights

• 300 ALS patients, randomized 2:1 (PrimeC : Placebo).
• 12-month, double-blind, placebo-controlled study.
• Conducted across the U.S. and EU.
• Open-label extension for long-term safety and efficacy insights.
• Adaptive design, enabling interim analyses for sample-size optimization and early signals of efficacy or futility.
• Powered at >95% to meet its primary endpoint.

NeuroSense will share more details about trial design and timelines in an investor webinar on December 8, 2025.

How PrimeC Works?

PrimeC is a novel extended-release oral therapy combining two FDA-approved drugs—ciprofloxacin and celecoxib—into a fixed-dose formulation.

PrimeC Targets Multiple ALS Pathways

• Motor neuron degeneration
• Neuroinflammation
• Iron accumulation
• Impaired RNA regulation

This multi-mechanism strategy mirrors emerging trends in neurodegeneration research, where single-target approaches have repeatedly fallen short.

PrimeC may also have implications for Alzheimer’s disease, given its overlapping pathology.

ALS in Context: The Urgency Behind the Work

ALS affects more than 5,000 new patients each year in the U.S. alone, generating an annual economic burden of over $1 billion.

By 2040, ALS prevalence is expected to rise 24% across the U.S. and EU.

This makes scalable, combination-driven therapies like PrimeC essential for the future of care.

About NeuroSense Therapeutics

NeuroSense is a clinical-stage biotech company developing therapies for neurodegenerative diseases including ALS, Alzheimer’s, and Parkinson’s. Their strategy focuses on combination therapies that address the complex and interconnected pathways driving these conditions.

More updates will be shared on the company’s website and social channels, where investor-relevant information may be posted regularly.